APPLICATION
NDA018887
TYPE
NDA
ORIGINAL APPROVAL
1985-12-05
LATEST ACTION
2004-02-11
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
INTALDiscontinued
CROMOLYN SODIUM 0.8MG/INH · AEROSOL, METERED · INHALATION
Approval history
1997-07-23Labeling · Supplement 17 · standardAP
1995-12-27Manufacturing (CMC) · Supplement 16 · standardAP
1995-12-21Manufacturing (CMC) · Supplement 15 · standardAP
1993-10-25Labeling · Supplement 14 · standardAP
1988-04-15Manufacturing (CMC) · Supplement 10 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 1 · standardAP
1986-01-31Labeling · Supplement 2AP
1985-12-05Type 3 - New Dosage Form · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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